User-centered approach to the development of a parent toolkit to improve willingness to participate in pediatric clinical research

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Abstract Pediatric clinical trials are needed to improve the medicines and treatments available for children and adolescents that are actually tested with youth rather than adults. However, recruitment barriers exist including: not understanding the importance of clinical trials, fear of procedures and unknown in research, mistrust in the research process, lack of knowledge about procedures, and worries about risks. Parents play an important role in the decision about whether their child can participate in a pediatric clinical trial. Parents need to be educated about clinical trials so that they can make an informed decision about participation and effectively communicate with their child about the research opportunity. Although there exists websites and YouTube videos that provide information on pediatric clinical trials, none of these resources provide parents with skills or strategies to use when communicating with others and participating in shared decision-making. Existing multimedia programs appear to only impact knowledge; however, changing attitudes and self-efficacy to make decisions about clinical trials are also important factors that can influence parents’ willingness to allow their child to participate in a clinical trial. With this R21, we aim to fill the gap in available resources for parents by creating an (English/Spanish language) web-based parent toolkit for parents of children (ages 7-17), which will provide information about clinical trials as well as provide opportunities for parents to practice and build communication, information-gathering, and shared decision-making skills. It is hypothesized that by using the web-based parent toolkit, parents will report an increase in their knowledge, positive attitudes, self-efficacy, and willingness to participate in clinical trials, as well as decrease in mistrust and fear. In Year 1, we develop the parent toolkit using a user/human-centered approach with feedback from multiple Advisory Panels of parents (diverse in terms of ethnicity, race, gender, child age, and trust in research) and Latino/a/x community group members , as well as toolkit review by expert consultants. The toolkit will be optimized for use on computers, mobile devices, and tablets, and tested for Section 508 compliance, thus increasing the accessibility and usability of the web-based toolkit. In Year 2, we will conduct a feasibility study with a sample of parents (N = 150), who will complete self-report measures about their knowledge, attitudes, fears, self-efficacy, and willingness to allow their child to participate in a clinical trial, as well as a consumer satisfaction questionnaire to provide feedback on the toolkit. The results of the R21 will lay the foundation for the development of web- based toolkit for parents that takes into account the perspectives of parents who are low in trust and familiarity with clinical trials as well as parents that are diverse in ethnicity, race, gender, and age of their child. The ultimate goal of this toolkit will be to increase the number of children and adolescents who are permitted to participate in clinical studies, which is needed to improve treatments for pediatric illnesses and diseases.